Quality Manager-ISO 13485/Medical Devices

Job Summary: Lead quality remediation and compliance programs for medical devices, ensuring adherence to FDA, ISO 13485, and global regulatory requirements. Provide leadership for QMS processes, audit readiness, CAPA governance, quality metrics, and continuous improvement initiatives across cross-functional teams. Key Responsibilities: Lead QMS, CAPA, Nonconformance, Complaint, and Audit programs.Support FDA inspections and regulatory audits.Drive quality remediation and compliance initiatives.M

Job Title: Quality Manager - Medical Devices Locations: Reedsville PA (Onsite) & Bothell WA (Onsite) Job Type: Fulltime Total Openings: 2 Salary: $130000 - $150000 per annum + Benefits Job Description: Lead quality remediation and compliance programs for medical devices, ensuring adherence to FDA, ISO 13485, and global regulatory requirements. Provide leadership for QMS processes, audit readiness, CAPA governance, quality metrics, and continuous improvement initiatives across cross-functional

Key Responsibilities Lead manufacturing quality assessments, audits, and remediation. Drive FPY improvement, defect reduction, and quality metrics. Review IQ/OQ/PQ, TMV, SPC, MSA, PFMEA, and process risk activities. Manage CAPA, nonconformance, and supplier quality issues. Support FDA, ISO 13485, MDSAP, and regulatory audits. Required 8+ years of medical device manufacturing quality experience. Strong Manufacturing Quality Engineering background. Experience with Class II/ medical devices. Hands-

Hi, Our client is looking for Quality Manager in Reedsville, PA below is the detailed requirement. Job Title: Quality Manager Location: Reedsville, PA Job Description: Bachelor's or Master's degree in Engineering or related discipline. 12+ years of Medical Device Quality experience. 5+ years of Quality Management leadership experience. ISO 13485 Lead Auditor or ASQ/CQI certification preferred. Experience supporting FDA inspections and remediation programs Medical Device Quality Manageme